Evaluation of Toxicities in Patients Treated With Palliative Radiotherapy at Policlinico Sant Orsola of Bologna.

Evaluation of Toxicities in Patients Treated With Palliative Radiotherapy at Policlinico Sant Orsola of Bologna - patieNts treAted wIth palliatiVe radiothErapy - NAIVE

The aim of the study is to assess the outcome in palliative patients, particularly in terms of symptom resolution or alleviation, after radiation treatment of the various tumours analysed, in relation to the treatment setting, dosages and techniques used both for newly diagnosed tumours and for cases already diagnosed and treated at the Radiotherapy Unit of the Sant Orsola Hospital.

Study Overview

• Status: Recruiting
• Conditions: Palliative Care

Detailed Description

Malignant neoplasms are frequent in the general population, particularly in countries with a high development index. In Europe, the incidence of malignant tumours in 2018 was almost 570 cases/100,000 inhabitants, while mortality in the same year was over 260 cases/100,000 inhabitants. In Italy, more than 175,000 new cancers were diagnosed in 2018, while the prevalence of malignant neoplasms in our country is 1990 cases/100,000 inhabitants. The therapy of neoplastic pathology is in most cases multimodal, and the various treatments can be adjuvant or neoadjuvant depending on the neoplasm treated and the strategy adopted from time to time. In addition, radiotherapy can play a key role in advanced disease, either with curative intent or with palliative intent on symptoms. Radiotherapy is one of the most effective means of providing palliation of cancer symptoms. The location of the symptom is essential to define a correct treatment plan, as the therapeutic approach will be different if the symptom is caused by the locally advanced primary tumour or by metastases. The symptoms most commonly relieved with palliative radiotherapy are pain, bleeding and obstruction.

Bone metastases are the most frequent cause of cancer-related pain and over 70% of patients with bone metastases are symptomatic. One of the most important goals in the treatment of bone metastases is to alleviate suffering and maintain an ability to manage daily activities. Radiotherapy plays a key role in improving the quality of life of these patients. Dosages, fractionations and techniques vary depending on the type of neoplasm treated, fractionations and techniques vary depending on the type of neoplasm treated, its location and the type of symptom to be palliated, as do the possible acute and late toxicities in relation to the characteristics of the treatment and, of course, the anatomical region irradiated. Systematic collection of data on palliative radiation treatment in different malignancies may make it possible to assess outcomes in relation to dosages, fractionation and techniques adopted in combination with other therapies, with the characteristics of the disease (bioprofile, histotype, stage, etc.) and of the patient (age, gender, comorbidities, etc...) The aim of the study is to evaluate the outcome in palliative patients, particularly in terms of symptom resolution or alleviation, after radiation treatment of the different tumours analysed, in relation to treatment setting, dosages and techniques used both for new neoplasm diagnoses and for cases already diagnosed and treated at the Radiatherapy Department of Sant Orsola Hospital.

The study is observational, retrospective and prospective, single-centre, spontaneous.

The structured collection of data necessary for the evaluation of the objectives will cover the period of observation period from 01/01/2000 to 31/12/2027.

• Study Type: Observational
• Enrollment (Estimated): 7000

Contacts and Locations

• Study Contact: Name: Alessio Giuseppe Morganti, MD; Phone Number: 0512143564; Email: alessio.morganti2@unibo.it
• Study Contact Backup: Name: Costanza Maria Donati, MD; Email: costanzamaria.donati@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero - Universitaria di Bologna
    • Contact: Alessio Giuseppe Morganti, MD; Phone Number: +39 0516363136; Email: alessio.morganti2@unibo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Every patient with a neoplastic disease admitted to the radiotherapy department for palliative or follow-up radiation treatment.

Description

Inclusion Criteria:

• adult patients of either sex with a new or previous diagnosis of malignant neoplasm since 1st January 2000
• patients treated with paliative radiotherapy
• obtaining of informed consent

Exclusion Criteria:

• adult patients of either sex with a new or previous diagnosis of malignant neoplasm who choose not to undergo radiotherapy treatment
• patients enrolled in other studies
• pregnant or breastfeeding women

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom resolution or attenuation	Evaluate the outcome in palliative patients, particularly in terms of symptom resolution or alleviation, after radiation treatment of the different tumours analysed, in relation to the treatment setting, dosages and techniques used	From the start of therapy to the last follow-up at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute toxicity in relation to different radiotherapy disages and techniques and patient characteristics	acute toxicity after radiotherapy, evaluated according to CTCAE v.5	immediate to 6 months after radiotherapy
Late toxicity in relation to different radiotherapy disages and techniques and patient characteristics	late toxicity after completion of treatments, evaluated according to CTCAE v.5	from 6 months after radiotherapy, through study completion, an average of 1 year
Incidence of reprocessing and its characteristics		During follow ups through study completion, an average of 1 year
Symptom-free survival	Disease-free survival assessed based on the presence or absence of local, nodal, or metastatic recurrences	During the follow-ups, up to the last one at 12 months
Overall survival		From enrollment to the last follow-up at 12 months

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Alessio Giuseppe Morganti, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NAIVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No